Humira Should Be Discontinued in Patients Diagnosed with Melanoma
Adalimumab (Humira) must be discontinued when melanoma is diagnosed, as TNF-blocker therapy increases malignancy risk and the FDA label specifically recommends considering risks and benefits before initiating or continuing therapy in patients with known malignancy other than successfully treated non-melanoma skin cancer. 1
FDA Drug Label Guidance
The adalimumab FDA label provides explicit direction on malignancy considerations:
Consider the risks and benefits of TNF-blocker treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing a TNF blocker in patients who develop a malignancy. 1
In controlled trials, more malignancies including melanoma were observed among TNF-blocker-treated patients compared to controls. 1
Melanoma was specifically identified as one of the most frequently observed malignancies (along with breast, colon, prostate, and lung cancers) in adalimumab-treated patients. 1
Clinical Decision Algorithm
Step 1: Immediate discontinuation - Stop Humira upon melanoma diagnosis given the explicit FDA warning about continuing TNF-blockers in patients who develop malignancy. 1
Step 2: Melanoma staging and treatment - Prioritize melanoma management according to stage:
- Resectable disease: Wide excision with margins determined by tumor thickness, with consideration of sentinel lymph node biopsy. 2
- Stage III disease: Surgery followed by adjuvant therapy (nivolumab, pembrolizumab, or dabrafenib plus trametinib for BRAF-mutant disease). 3
- Stage IV/metastatic disease: Systemic therapy with checkpoint immunotherapy (ipilimumab plus nivolumab, nivolumab, or pembrolizumab) or targeted therapy for BRAF-mutant disease. 3
Step 3: Reassess underlying condition - After melanoma treatment is complete and the patient achieves remission, evaluate alternative therapies for the original indication that prompted Humira use, avoiding TNF-blockers indefinitely.
Critical Safety Considerations
Malignancy risk is cumulative with TNF-blocker exposure:
- The rate of non-melanoma skin cancer was 0.8 per 100 patient-years in adalimumab-treated patients versus 0.2 per 100 patient-years in controls. 1
- Lymphoma rates were also elevated in TNF-blocker treated patients. 1
No safe window for resumption - The FDA label does not provide guidance on when or if TNF-blocker therapy can be safely resumed after melanoma treatment, implying permanent discontinuation is the safest approach. 1
Common Pitfalls to Avoid
Do not continue Humira "until melanoma treatment starts" - The increased malignancy risk with ongoing TNF-blocker exposure necessitates immediate discontinuation. 1
Do not assume melanoma stage determines continuation - Even early-stage melanoma warrants discontinuation given the FDA's broad recommendation against continuing TNF-blockers in patients who develop any malignancy (except successfully treated NMSC). 1
Do not restart after melanoma remission without extreme caution - While the FDA label discusses initiating therapy in patients with "a known malignancy," melanoma's aggressive nature and the documented increased melanoma risk with adalimumab make resumption inadvisable. 1